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Feminism: Sex and gender discussions

NICE Evidence Review for Use of Puberty Blockers for GD - Now Released

192 replies

IDontOnlyLikeJazzFunk · 31/03/2021 14:09

now released. NC. The full link is below, this is the summary. It's not looking good.

Discussion
A key limitation to identifying the effectiveness and safety of GnRH analogues for children and adolescents with gender dysphoria is the lack of reliable comparative studies. The lack of clear, expected outcomes from treatment with a GnRH analogue (the purpose of which is to suppress secondary sexual characteristics which may cause distress from unwanted pubertal changes) also makes interpreting the evidence difficult.

The studies included in this evidence review are all small, uncontrolled observational studies, which are subject to bias and confounding, and all the results are of very low certainty using modified GRADE. They all reported physical and mental health comorbidities and concomitant treatments very poorly. All the studies are from a limited number of, mainly European, care facilities. They are described as either tertiary referral or expert services but the low number of services providing such care and publishing evidence may bias the results towards the outcomes in these services only and limit extrapolation.

Many of the studies did not report statistical significance or confidence intervals. Changes in outcome scores for clinical effectiveness and bone density were assessed with regards to statistical significance. However, there is relatively little interpretation of whether the changes in outcomes are clinically meaningful.
In the observational, retrospective studies providing evidence on bone density, participants acted as their own controls and change in bone density was determined between starting GnRH analogues and follow up. Observational studies such as these can only show an association with GnRH analogues and bone density; they cannot show that GnRH analogues caused any differences in bone density seen. Because there was no comparator group and participants acted as their own controls, it is not known whether the findings are associated with GnRH analogues or due to changes over time.

Conclusion
The results of the studies that reported impact on the critical outcomes of gender dysphoria and mental health (depression, anger and anxiety), and the important outcomes of body image and psychosocial impact (global and psychosocial functioning), in children and adolescents with gender dysphoria are of very low certainty using modified GRADE. They suggest little change with GnRH analogues from baseline to follow-up.

Studies that found differences in outcomes could represent changes that are either of questionable clinical value, or the studies themselves are not reliable and changes could be due to confounding, bias or chance. It is plausible, however, that a lack of difference in scores from baseline to follow-up is the effect of GnRH analogues in children and adolescents with gender dysphoria, in whom the development of secondary sexual characteristics might be expected to be associated with an increased impact on gender dysphoria, depression, anxiety, anger and distress over time without treatment. The study by de Vries et al. 2011 reported statistically significant reductions in the Child Behaviour Checklist (CBCL) and Youth Self-Report (YSR) scores from baseline to follow up, which include measures of distress. As the aim of GnRH analogues is to reduce distress caused by the development of secondary sexual characteristics, this may be an important finding.

However, as the studies all lack appropriate controls who were not receiving GnRH analogues, any positive changes could be a regression to mean.

The results of the studies that reported bone density outcomes suggest that GnRH analogues may reduce the expected increase in bone density (which is expected during puberty). However, as the studies themselves are not reliable, the results could be due to confounding, bias or chance. While controlled trials may not be possible, comparative studies are needed to understand this association and whether the effects of GnRH analogues on bone density are seen after they are stopped. All the studies that reported safety outcomes provided very low certainty evidence.

No cost-effectiveness evidence was found to determine whether or not GnRH analogues are cost-effective for children and adolescents with gender dysphoria.

The results of the studies that reported outcomes for subgroups of children and adolescents with gender dysphoria, suggest there may be differences between sex assigned at birth males (transfemales) and sex assigned at birth females (transmales).

arms.nice.org.uk/resources/hub/1070905/attachment

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IDontOnlyLikeJazzFunk · 01/04/2021 16:36

@DadJoke

The NHS offers Triptorelin. It's not the same drug.
thanks Janie and gosh! Sophocles that sounds terrible!! Thanks Dadjoke - do you happen to know if Triptorelin is the only puberty blocker offered by the NHS or are there alternatives?

If it is the only one I wonder how they have decided to use that particular one (in the absence of good data). It is interesting that for a condition that involves depression or anxiety, the known side effects for Triptorelin include: Depression, mood altering and possible side effects are anaphylactic reaction, haemorrhage, nausea, vaginal discharge and vomiting.

One of the uses of Lupron in the US is for endometriosis and it seems that it has been found to be almost entirely ineffective for that purpose so it is a bit bizarre that they have been prescribing for that.

The NICE website lists the following in this group of drugs for precocious puberty (obviously nothing recommended currently for gender dysphoria). It is my understanding that these are Gonadotrophin Releasing hormone Analogues (GNrH) and therefore of the same class as Lupron.

Gonadorelin
Lueprorelin acetate
Triptorelin

Obviously living in hope these drugs are not as toxic as Lupron, (although Sophocles' experience sounds pretty bad) - it would be quite appalling if they were. It does beg the question however, that if there are alternative drugs available that do the same job as Lupron, but with significantly less dangerous side effects, why on earth are the Americans prescribing Lupron for anyone?.

We also have a slight issue in the UK where there are a number of private clinics and GenderGP who are prescribing puberty blockers to children and no one has any idea what they are prescribing. They are actively working against any safeguarding guidelines, will prescribe to children without the knowledge of their parents so can we trust them to prescribe the 'safest' version of pbs (if you can call it that)?

There are also children being encouraged by certain groups to buy their medication over the internet - who knows what they are buying - obviously there are Americans who are very prepared to sell Lupron quite openly - again, there is no way of knowing what the children are buying.

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EmbarrassingAdmissions · 01/04/2021 16:11

@rogdmum

England and Wales though Scotland normally take on their reports. The scottish equivalent is SIGN (Scottish Intercollegiate Guidelines Network) but they are a lot smaller operation.

I emailed SIGN this morning to ask about any response to the NICE review or whether it is worth doing a topic proposal.

I'd be surprised if SIGN wanted to repeat an evidence review (which is what NICE did) - the interpretation of the evidence and operationalisation (so to speak) would be up to the equivalent of the NHS E Working Group (the Cass Review) if there is one.
Sophoclesthefox · 01/04/2021 16:06

It’s triptorelin that’s used in the UK, which is a different drug from Lupron, but very similar effects.

I was on it for six months, and it is an appalling drug. I was given it for endometriosis (a disease that only affects women, of course). It is not particularly effective for that, either.

The side effects were horrendous, and it may have caused lasting health effects, likely caused my infertility, and was likely one of the causes of my extremely early menopause, which is currently threatening to wreck my previously very successful career. In my opinion, it should never be given to children whose bodies and brains are still developing. And Particularly not for childhood gender identity disorder, with its vague diagnostic criteria and the utter paucity of evidence of efficacy.

I’ll never not oppose its use.

(No sympathy required, by the way, I am fine really Smile)

rogdmum · 01/04/2021 15:51

England and Wales though Scotland normally take on their reports. The scottish equivalent is SIGN (Scottish Intercollegiate Guidelines Network) but they are a lot smaller operation.

I emailed SIGN this morning to ask about any response to the NICE review or whether it is worth doing a topic proposal.

Thingybob · 01/04/2021 15:40

NHS STANDARD CONTRACT
FOR GENDER IDENTITY DEVELOPMENT SERVICE FOR CHILDREN AND ADOLESCENTS
SCHEDULE 2 – THE SERVICES A. SERVICE SPECIFICATION

www.england.nhs.uk/wp-content/uploads/2017/04/gender-development-service-children-adolescents.pdf

That's the contract that the NHS has with GIDS. As you say there is a lot of cut n' paste from WPATH and the various lobby groups were consulted on the type of service they wanted as well as the wording of the document.

I believe the Cass review and the evidence from NICE will provide the foundations for a new service specification going forward.

WiseUpJanetWeiss · 01/04/2021 15:29

So after those three things surely what we have is a situation where a) only parents/carers can decide ultimately that their child should take these drugs b) any ethical doctor can only ask those parents "do you consent to this experiment" not "do you consent to this medical treatment"

TheMost I don’t think that’s quite right. For the treatment to be experimental it would need to be part of a clinical trial. This is off label (unlicensed) use of a medicine that is licensed for another purpose (pausing precocious puberty or threatment of prostate cancer, depending on which one is used). It’s perfectly legal to prescribe off label, but the prescriber takes additional responsibilities for safety and efficacy: www.gov.uk/drug-safety-update/off-label-or-unlicensed-use-of-medicines-prescribers-responsibilities

It’s difficult to see how the prescribing of these medicines for preventing puberty can possibly meet the requirements of the bullet pointed list at the end of the article. I would be disappointed if off label use of these medicines doesn’t appear in an updated version, as well as some clarification around the communication of off-label status, but I guess the MHRA is a bit busy at the moment...

EmbarrassingAdmissions · 01/04/2021 15:18

I was screening some publications this morning (reasons) and saw a description of surgery (not a GID related topic) that read like it could be an RCT but seemed flirting with ethical issues to do it that way. I was about to pass it by but noticed the data (the 1970s) so decided to take a closer look. It was a randomised trial - the past was another country.

AfternoonToffee · 01/04/2021 15:13

It was noted on another thread that parents are not given free reign to do what they want with their children. They cannot consent for a child to get a tattoo for example. Nor can they consent for their child to be married. Parental authority over their child is limited.

Yes, something that was heavily bearing on the Charlie Hard and Alfie Evans cases with the right of the child is paramount and parents do not have the final say. Surely Bell will have less (none) effect on Gillick then the GLP railroading will have on the Convention for the rights of the child.

It sure is a mess, and it is such a mess because things have allowed for the train to not only have any brakes, there are no blinking rails in the first place.

DadJoke · 01/04/2021 15:05

The NHS offers Triptorelin. It's not the same drug.

yourhairiswinterfire · 01/04/2021 14:24

Thank you IDontOnlyLikeJazzFunk, sounds like that is what was being referred to in the post I saw.

WarriorN · 01/04/2021 14:23

I believe there are other types of PBs, I remember googling it once and it's not specifically lupron used in nhs GIDs, but I can't remember exactly what.

I was just trying to find the difference types and I stumbled across this.

It was to be reviewed in 2019 and ran out last year.

Interesting in the light of the nice review.

There's a great deal of info on how nhs GIDS work, including references to WPATH and the Dutch protocol.

NHS STANDARD CONTRACT
FOR GENDER IDENTITY DEVELOPMENT SERVICE FOR CHILDREN AND ADOLESCENTS
SCHEDULE 2 – THE SERVICES A. SERVICE SPECIFICATION

www.england.nhs.uk/wp-content/uploads/2017/04/gender-development-service-children-adolescents.pdf

Janie143 · 01/04/2021 14:19

It's exactly the same chemically "05IDontOnlyLikeJazzFunk* It's just named differently in different countries

EmbarrassingAdmissions · 01/04/2021 14:13

@Manderleyagain

Is NICE for the whole of the UK, or it only England and Wales? The clinic in Glasgow didn't change anything in response to Bell because it was English high court, but will they have to respond to this?
NICE largely is NHS England and Wales.

The exception is when, for various reasons, the work together with SIGN for NHS Scotland and the special section for NI.

IDontOnlyLikeJazzFunk · 01/04/2021 14:05

@yourhairiswinterfire

I read a comment here a while ago about a class action lawsuit regarding the use of PB's, may have been about their use in treating precocious puberty? Does anyone know if that's happening, because I can't remember if what I read was speculation that there'll be a lawsuit, or there actually is one.

I've tried Googling but I just get the Bell v Tavi articles.

I think it might be in the US - Lupron is a GnRH which is a prostate cancer drug also used to treat endometriosis (unsuccessfully in almost all cases), fibroids and precocious puberty. I'm not sure what progress the proposed class action is making.

People administering the drug to a patient have to wear full ppe and avoid trying to conceive a child for 3 months.

25,000 adverse events reported, 25 deaths, a reported serious side effects list as long as your arm. I am wondering why anyone would be prescribing that to anyone ever.

The puberty blockers prescribed in the UK are the same class of drugs but hopefully they are of some sort of type that is less harmful than Lupron??

nwhn.org/lupron-what-does-it-do-to-womens-health/

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Tibtom · 01/04/2021 13:50

@Manderleyagain

Is NICE for the whole of the UK, or it only England and Wales? The clinic in Glasgow didn't change anything in response to Bell because it was English high court, but will they have to respond to this?
England and Wales though Scotland normally take on their reports. The scottish equivalent is SIGN (Scottish Intercollegiate Guidelines Network) but they are a lot smaller operation.
OldCrone · 01/04/2021 13:40

@vivariumvivariumsvivaria

Well, I mean that they have "patients" (for want of a better word) in positions of authority within the organisation. Who then steer the approach, which has massive influence in the NHS and government and organisations.

Everything else in health care works from evidence first, not from patient desire first.

I genuinely can't think of any other field of healthcare where the patient/client is given such authority. THey'll listen to patient experts, they'll consult and work with them, but, the decision making is firmly based on evidence, not on what the patient believes they need.

I posted this on another thread about the Tavistock yesterday, where the minutes of the board of directors meeting were being discussed.

tavistockandportman.nhs.uk/documents/143/board-papers-2015-07.pdf

On p 8-9, there is a report of two young patients at GIDS speaking to the board, and it includes this:

Ms I added that she appreciated that the Trust was involving her and the other young people in the service, getting their feedback, and listening to their point of view. She added that they had sat on an interview panel that morning, and it was really good to be on the other side of the table for once.

It doesn't give any information about the interview in question, but it struck me as odd that two very young people (as current patients they must have been under 18), were asked to do this.

yourhairiswinterfire · 01/04/2021 13:34

I read a comment here a while ago about a class action lawsuit regarding the use of PB's, may have been about their use in treating precocious puberty? Does anyone know if that's happening, because I can't remember if what I read was speculation that there'll be a lawsuit, or there actually is one.

I've tried Googling but I just get the Bell v Tavi articles.

Manderleyagain · 01/04/2021 13:32

Is NICE for the whole of the UK, or it only England and Wales? The clinic in Glasgow didn't change anything in response to Bell because it was English high court, but will they have to respond to this?

DadJoke · 01/04/2021 13:29

@R0wantrees

BBC report says a control group would be difficult because you couldn't withhold treatment from one group.

The BBC article says, " Some argue that carrying out a controlled trial - which would provide better quality evidence - might be difficult because of the potential impact on mental health if treatment is withheld in one group."
Its unfortunate that BBC does not identify who are those making such an argument as clarity is important.

I think the BBC are relying in the NICE document, which says:

"There may also be ethical issueswith a ‘no treatment arm’ in comparative trials of GnRH analogues, where there may be poor mental health outcomes if treatment is withheld."

It goes on to say:

"However, the use of an active comparator such as close psychological support may reduce ethical concerns in future trials."

vivariumvivariumsvivaria · 01/04/2021 13:26

Well, I mean that they have "patients" (for want of a better word) in positions of authority within the organisation. Who then steer the approach, which has massive influence in the NHS and government and organisations.

Everything else in health care works from evidence first, not from patient desire first.

I genuinely can't think of any other field of healthcare where the patient/client is given such authority. THey'll listen to patient experts, they'll consult and work with them, but, the decision making is firmly based on evidence, not on what the patient believes they need.

Thingybob · 01/04/2021 13:20

WPATH is effectively a patient lobby group

I don't agree with that statement as most WPATH members seem to be professionals in 'gender medicine'. I do however accept that many members appear to have vested interests.

WarriorN · 01/04/2021 13:14

According to twitter (mimmymummy), "Susie Green was chosen by WPATH as the only non-medical/research contributor to the Children’s chapter" (in reply to a tweet by Helen Watts of girl guiding.)

4thwavenow.com/2017/10/21/should-mermaids-be-permitted-to-influence-uk-public-policy-on-trans-kids/

NICE Evidence Review for Use of Puberty Blockers for GD - Now Released
MaudTheInvincible · 01/04/2021 13:12

@vivariumvivariumsvivaria

WPATH is effectively a patient lobby group. Quite why they have been given so much credence by psychiatrists, medics and scientists is a total mystery to me. No other patient group has achieved this.

The type of activism surrounding this patient group is not a million miles away from the types of groups attracted by the cases of Charlie Gard and Alfie Evans, imo. I see the same type of discourse and narrative being used here.

InvisibleDragon · 01/04/2021 13:07

I think we are getting towards the point where it becomes clear that adults cannot consent on behalf of their children you receive this treatment.

It was noted on another thread that parents are not given free reign to do what they want with their children. They cannot consent for a child to get a tattoo for example. Nor can they consent for their child to be married. Parental authority over their child is limited.